近几十年来,严重产后出血(sPPH)的医疗管理取得了重大进展,这反映在许多已发布的指南中。迄今为止,许多当前可用的国家和国际指南建议重组因子VIIa(rFVIIa)仅在sPPH过程的非常后期使用,作为“最后手段”,子宫切除术前或后。根据新的安全数据,rFVIIa最近已被欧洲药品管理局(EMA)和Swissmedic批准用于sPPH,如果子宫收缩剂不足以实现止血,事实上,这在产后出血(PPH)的过程中明显更早。因此,我们的目标是制定专家共识指导,以通过使用rFVIIa来管理危及生命的sPPH妇女的临床医生来实现标准化护理。
■共识过程包括与九名专家的一次面对面会议,包括八名妇产科医生和一名在三级护理围产期中心的sPPH护理方面经验丰富的血液学家。该小组代表了欧洲产科界的多学科专业知识,并就rFVIIa在sPPH管理中的临床实践中的预定义问题提供了共识意见。建议是根据当前的国家和国际准则提出的,丰富的临床经验,和共识意见,以及有效性和新的安全性数据的可用性。
专家小组针对在sPPH管理中使用rFVIIa的13个预定义问题,制定了17项共识声明,其中包括:现有的疗效和安全性数据以及产科医生之间对跨学科专业知识的需求。麻醉师,和血液学家在sPPH的管理中。根据新的数据,专家建议:(1)对子宫收缩给药无反应的sPPH患者早期给予rFVIIa,以优化rFVIIa的疗效;(2)rFVIIa给药前血液学参数先决条件的重要性,以最大化疗效;(3)根据标准实践继续评估或启动进一步的侵入性程序.此外,在一系列指定的临床场景和设置中概述了sPPH管理算法中rFVIIa治疗时机的建议,包括阴道分娩,剖宫产,和较小的分娩单位,然后转移到三级护理中心。小组同意,根据现有资料,和新的数据,以及现实世界的经验,没有证据表明sPPH患者使用rFVIIa会增加血栓栓塞的风险.作者承认,临床有效性数据仍然有限,以及药物经济学数据,关于rFVIIa在sPPH中的使用,并建议进一步的临床试验和疗效研究。
■该专家小组根据最近可用的数据提供共识指导,临床经验,和专家意见,EMA最近批准rFVIIa用于sPPH。这些共识声明旨在支持sPPH的临床护理,并可能有助于为现有临床实践指南的更新提供动力和起点。
UNASSIGNED: There have been significant advances in the medical management of severe postpartum hemorrhage (sPPH) over recent decades, which is reflected in numerous published
guidelines. To date, many of the currently available national and international
guidelines recommend recombinant factor VIIa (rFVIIa) to be used only at a very late stage in the course of sPPH, as a \"last resort\", before or after hysterectomy. Based on new safety data, rFVIIa has recently been approved by the European Medicines Agency (EMA) and Swissmedic for use in sPPH, if uterotonics are insufficient to achieve hemostasis, which in fact is significantly earlier in the course of postpartum hemorrhage (PPH). We therefore aimed to develop expert consensus guidance as a step toward standardizing care with the use of rFVIIa for clinicians managing women experiencing life-threatening sPPH.
UNASSIGNED: The consensus process consisted of one face-to-face meeting with a group of nine experts, including eight obstetrician-gynecologists and a hematologist highly experienced in sPPH care in tertiary care perinatal centers. The panel was representative of multidisciplinary expertise in the European obstetrics community and provided consensus opinion in answer to pre-defined questions around clinical practice with rFVIIa in the management of sPPH. Recommendations have been based on current national and international
guidelines, extensive clinical experience, and
consensus opinion, as well as the availability of efficacy and new safety data.
UNASSIGNED: The expert panel developed 17 consensus statements in response to the 13 pre-defined questions on the use of rFVIIa in the management of sPPH including: available efficacy and safety data and the need for interdisciplinary expertise between obstetricians, anesthesiologists, and hematologists in the management of sPPH. Based on novel data, the experts recommend: (1) earlier administration of rFVIIa in patients with sPPH who do not respond to uterotonic administration to optimize the efficacy of rFVIIa; (2) the importance of hematological parameter prerequisites prior to the administration of rFVIIa to maximize efficacy; and (3) continued evaluation or initiation of further invasive procedures according to standard practice. Furthermore, recommendations on the timing of rFVIIa treatment within the sPPH management algorithm are outlined in a range of specified clinical scenarios and settings, including vaginal delivery, cesarean section, and smaller birthing units before transfer to a tertiary care center. The panel agreed that according to available, and new data, as well as real-world experience, there is no evidence that the use of rFVIIa in patients with sPPH increases the risk of thromboembolism. The authors acknowledge that there is still limited clinical effectiveness data, as well as pharmacoeconomic data, on the use of rFVIIa in sPPH, and recommend further clinical trials and efficacy investigation.
UNASSIGNED: This expert panel provides consensus guidance based on recently available data, clinical experience, and expert opinion, augmented by the recent approval of rFVIIa for use in sPPH by the EMA. These consensus statements are intended to support clinical care for sPPH and may help to provide the impetus and a starting point for updates to existing clinical practice
guidelines.